Global Auditing & Remediation Services

FDA, EMA, ISO Mock & PAI Audits
Vendors & Supplier Audits

GMP/GLP/GCP GXP Audits - Excipients / APIs
Medical Device - QMS/QSR Audits - ISO 13485:2016
Vendor - Supplier Audits, CMOs, CDMOs
Laboratory Audits - GLP/GCLP - Part 58/OECD GLP
21 CFR Part 11 Systems & Software Compliance
Validation Audits / Writing - Process & Equipment
Dietary Supplements & Cosmetics Manufacturing
Company Acquisitions & Compliance Audits
Mock FDA, EU, NMPA & WHO Audits
Remediation, Validation & Gap Analysis Reports
Clinical Audits, CROs, GCLP, Investigator Sites

GxP Audits

All Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by TAG, ASQ and Global Accepted Certifications!

GMP Audits - API/Excipients
GLP Audits - QC, Testing and LIMs,
Mock FDA/EMA, PAI, Pre-ISO
Vendors, Suppliers and Contractors
Pharmaceuticals / Supplements
Medical Devices / IVDs
Cosmetics
Biologics, Blood, Cell, Tissue
Validation Audits
Engineering Audits
Document Audits
Clinical Audits
Investigator Sites
Clinical Data Management
Clinical Electronic Systems

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Remediation

The Auditing Group SMEs have the Experience to assist with your remediation efforts, whether satisfying a 'For-Cause' US FDA 483, Agency Warning Letter, or audit observations, we have the resources and tools to assist with your successful compliance endeavors.

Project Management
CAPA Management
Procedure Development
Protocol Development
Design / Build Engineering Analysis
As-Built Qualifications
Commissioning and Qualifications
Validation Services

Turn-key or Hourly SME Quotes!

Gantt Driven Project Management

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Training

The Auditing Group has teamed up with GMP Boot Camps to provide on-site or Virtual training for your Employees to satisfy your GxP requirements.

Basic 1, 2, or 3-day GMP / QMS for Drug, Medical Device, Cosmetics or Dietary Supplements Training
Focused Training Programs - Taylored to your Company's Products, Services or Capabilities - Includes an on-site pre-training Audit of your GXP Compliance for training applicability.